First Clinical Trial on Geniculate Artery Embolization for Knee Pain

Research and results from the first US clinical trial on geniculate artery embolization (GAE), a minimally invasive, image-guided treatment that blocks key arteries in the knee to reduce inflammation and pain, was presented at the Society of Interventional Radiology’s 2018 Annual Scientific Meeting.1 This nonsurgical treatment could improve quality of life for patients with knee pain due to osteoarthritis (OA).

By inserting catheters through a pinhole-sized incision, interventional radiologists perform geniculate artery embolization for knee pain, blocking arteries or capillaries within the lining of the knee, reducing the inflammation caused by osteoarthritis. As an outpatient treatment, GAE does not require open surgery or physical therapy and takes between 45 and 90 minutes to perform.1 In a media briefing before the event,2 Dr. Sandeep Bagla, MD, director of interventional radiology at the Vascular Institute of Virginia commented on the radiation involved in the procedure, noting that the amount is very minimal due to the x-rays being focused on one smaller area of the body (the knee) and that the exposure is not of concern.

“This procedure could have a significant impact in the treatment of osteoarthritis pain as a whole,” said Dr. Bagla in the presentation’s abstract. “The current treatment in patients who have arthritis are pain medications, which come with significant side effects and risks. GAE provides another option for patients struggling with pain and may even allow patients to avoid the painful recovery of knee surgery.”

The prospective, multicenter clinical trial evaluated 13 patients with severe OA pain. Each patient’s pain and disability were measured along two scales, with evaluations before and after the treatment. One month later, researchers followed the progress of eight patients and found that GAE significantly decreased pain (-58 mm on the Visual Analog Scale), reduced stiffness and increased physical function (-36.3 on the Western Ontario and McMaster University Osteoarthritis Index).The treatment was successfully completed and no adverse events were reported.1

Dr. Steven S. Raman, MD, professor of radiology and urology at the David Geffen School of Medicine at the University of California and fellow presenter at the SIR meeting, commented on Dr. Bagla’s research in the media briefing, saying, “I think that the biological mechanism here is that there is inflammation and proliferation of the synovia and new blood vessels there, and this therapy is very well-targeted at that particular mechanism. Certainly it should be investigated further, and more detailed prospective testing in larger scale trials with a broader range of patients is certainly important. I’m really looking forward to expediting and accelerating and finding ways to support this important research moving forward.”

Together, the scales represent an 80 percent improvement in function compared with pre-procedure conditions.Indeed, a majority of study participants achieved significant pain reduction and improvements in range of motion, which may help them avoid more invasive measures.1

“A majority of our patients with osteoarthritis of the knee saw significant pain reduction, not only just a few days after the procedure, but a month after as well, making this an accessible treatment for patients looking to improve their quality of life without surgery,” Dr. Bagla said. “We are very encouraged by the results and the implications for the millions suffering from this common, yet debilitating condition.”

The study builds on already established international research around geniculate artery embolization and osteoarthritis. While preliminary data shows that the treatment does work and is feasible, it has only been used in a clinical trial setting.1

In the media briefing,2 Dr. Bagla also discussed his vision for the future of the GAE procedure and how it will be implemented into clinical practice. “Our current hope is that we can actually prove that not only is GAE safe and feasible, but can actually treat patients for their knee pain who are not yet ready for knee replacement,” he said. “These [are] patients, perhaps between the ages of 40 and 70, who do not actually want to undergo a major operation, or patients who are taking chronic pain medications. Perhaps we can demonstrate and prove that patients do not need to be on these medications and alternatively can go through a minimally invasive procedure like this to reduce their knee pain.”

The study has completed enrollment of 20 patients and final results are expected in the summer 2018. A second randomized controlled clinical trial that began in February 2018 will provide further data on what types of patients are the best candidates for this treatment and how it could move toward clinical practice.1

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